Job Description

Within a start-up environment, the Director of R&D – Electrophysiology provides functional leadership to core teams of project management, process development engineers, manufacturing engineers, automation engineers, and technicians responsible for the successful execution of global new product and process development initiatives within the electrophysiology product space. The Director of R&D - Electrophysiology must possess the ability to define functional objectives supportive of overall strategic goals, drive effective execution across a diverse portfolio of projects and develop people. These teams may exist across multiple sites and work across multiple product areas with a focus on electrophysiology catheter development for our medical device OEM customers.

This position is based out of our Fridley, MN location with travel up to 50% to our Costa Rica site.

What You’ll Do Every Day:

• Lead teams responsible for owning process development from concept through transfer including process capability, process quality deliverables, process cost, and technology improvements.
• Provide direction to technical resources at both the manager and individual contributor levels while identifying and supporting the developmental needs across the team.
• Provide technical and direction for process characterization skills and tools such as Design of Experiments (DOE), pFMEA, mitigation to foreseen risks, and capability analysis. This knowledge may be leveraged across various technologies as needed.
• Accurately and effectively report and communicate progress and issues to leadership in order to support project objectives.
• Partner effectively and proactively with other functional leaders and teams including Project Management, Product Engineering, Operations, Quality, Commercial, Regulatory, Portfolio Management, and others as applicable.
• Support Project Management in the execution of a project portfolio by understanding and setting priorities, managing resources and mitigating risks in order to achieve milestones.
• Support Project Management with accurate assessments of functional capabilities execution status.
• Ensure that proper technology processes are developed, implemented, maintained, and documented to successfully introduce new products into manufacturing. Involved in prototyping, process development, process characterization, and validation (OQ/PQ support at transfer site).
• Assume responsibility for completeness and accuracy of developed processes (i.e., lead, manage, communicate, complete documentation, train) including ownership of process capability, process quality, and process costs.
• Align and optimize team performance across sites and project teams to make best use of available skills and resources.
• Coordinate new equipment identification, procurement, installation qualification (IQ), document creation, and training.
• Identify new technologies in accordance with site and customer priorities to improve efficiency, quality, reduce costs, and meet market technology needs.
• Responsible for the costing of projects and support of costing for high volume pricing.
• Lead and develop a team of individual contributors and managers by recruiting, assigning work, setting clear and achievable goals, providing ongoing coaching and feedback, and managing performance and career development in alignment with company policies and applicable laws.
• Other duties may be assigned as required.

What We’re Looking For:

• Bachelor degree in Mechanical Engineering or a related technical field required; Master’s degree preferred.
• Minimum 10 years of relevant experience in technical/medical device development and/or manufacturing experience.
• Minimum of 5 years of previous management and leadership experience required.
• Experience in the field of electrophysiology catheters required.
• Six sigma background or lean manufacturing experience preferred
• Demonstrates strong leadership, communication and managerial skills
• Experience in various medical device areas such as neuromodulation and interventional a plus
• Must be willing and able to travel up to 50%, mainly between Minnesota and Costa Rica.

Medevio is committed to providing competitive total compensation and benefits packages. The expected hiring range for this position is between $160,000 and $190,000 based upon a full-time schedule. This is a good faith estimate on the applicable range. Base salaries are determined by taking a variety of factors in account, including, but not limited to, candidate qualifications, geographic locations, market conditions and internal equity. This position is bonus eligible, with a target bonus of 20%. Our total compensation package includes eligibility for comprehensive medical, dental, and vision coverage, a 401(k) plan with company match, education reimbursement, paid parental leave and paid time off.

ReqID: 59781